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Maximizing PDUFA V Meeting Opportunities Requires Work By Sponsors

 
• By Sue Sutter

To get the most out of formal interactions with the agency, sponsors must prepare thoroughly and listen for FDA “regulatory speak,” agency and industry representatives advise.

Enhanced communication between FDA and sponsors is one of the underlying principles of the PDUFA V reauthorization, but maximizing the value of those interactions requires thorough preparation and careful listening on the part of the company, according to industry and agency representatives.

During a panel discussion at the recent Mid-Atlantic BIO meeting, current and former FDA officials and industry employees offered best...

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More from North America

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• By Sarah Karlin-Smith

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